Kornimate/medical-research-clean huggingface dataset:
how atorvastatin affects the gut flora and metabolomics?

Conditions: Atherosclerotic Cardiovascular Disease

Summary: recent studies suggest that gut microbiome, the microbial community in the intestine, may directly and indirectly influence the progression of atherosclerosis. the imbalance of gut microbiome may directly promote the formation of atherosclerotic plaques by promoting the inflammatory reaction and oxidative stress affecting vascular endothelial function and increasing platelet activity. meanwhile, it can indirectly increase the risk of atherosclerosis by enhance insulin resistance, reducing the production of bile acids and raising serum ldl-c and angiotensin levels. as shown in these researches, gut microbiome, acting as a bridge between metabolism, energy and inflammatory responses, may play an important role in cardiovascular diseases, and we believe that the interaction between microbiome and host should be considered in the ascvd study.


Eligibility criteria:
inclusion criteria: * age 18-80 years; * statin indications such as lipid metabolism disorders, diabetes, elevated crp, atherosclerosis; stratification according to ascvd risk; indications for statin treatment * not using statins and other lipid-lowering drugs for at least 6 months before enrollment; * agree to receive research treatment plan; * voluntarily sign the informed consent. exclusion criteria: * people with active gastrointestinal bleeding or have a clear history of gastrointestinal ulcers or bleeding in the past 2 years; * severe renal insufficiency (egfr \<30ml / min / 1.73m2); * active hepatitis, liver cirrhosis, or alt increase more than 3 times; * those with severe hypertension (\> 180 / 110mmhg) and currently have no control; * hemoglobin \<100g / l; * platelet count \<100 × 109 cells / l; * suffering from a known serious progressive disease (such as a malignant tumor) or a disease that causes the patient to fail extremely, the estimated survival time is \<12 months; * pregnant or intending to become pregnant; * any situation that may interfere with the research process, such as dementia, paralysis, alcoholism, etc .; * expected to undergo surgery within 1 year; * patients participating in other ongoing clinical studies.
neoadjuvant chemotherapy with or without talniflumate for the treatment of breast cancer

Conditions: Breast Cancer

Summary: rationale: talniflumate, a prodrug of niflumic acid with significant anti-inflammatory properties, has emerged as a promising candidate in breast cancer therapy due to its ability to modulate key oncogenic pathways. its mechanisms of action include the inhibition of cyclooxygenase (cox) enzymes, which mitigates tumor-promoting inflammation and fosters a less permissive microenvironment for cancer progression. additionally, talniflumate disrupts ionic homeostasis by targeting calcium-activated chloride channels (caccs), leading to impaired cellular proliferation and potential induction of apoptosis. the agent also exhibits anti-angiogenic activity by downregulating vascular endothelial growth factor (vegf), thereby restricting tumor vascularization and growth. furthermore, talniflumate shows potential as a chemosensitizer, enhancing the cytotoxic effects of standard chemotherapy and improving therapeutic outcomes while reducing chemoresistance. these multifaceted mechanisms highlight the therapeutic promise of talniflumate in breast cancer, warranting further preclinical and clinical studies to validate its efficacy, refine dosing strategies, and define its role in combination therapies. purpose: to assess the therapeutic efficacy of talniflumate in the management of breast cancer, with a focus on its synergistic interactions with neoadjuvant chemotherapy.


Eligibility criteria:
inclusion criteria: * age: ≥ 18 and ≤ 75 years, female; * the breast cancer has been confirmed by pathological examination and immunohistochemistry (ihc); * not receiving any preoperative anticancer drugs; * the liver and kidney function satisfies the following conditions within 3 days after surgery (excluding day 3): aspartate aminotransferase (ast), glutamic-oxalacetic transaminase (alt) \< 2 upper limit of normal (uln), total bilirubin ≤ 1.5 uln, serum creatinine \< 1.5 uln; * other laboratory tests meet the following requirements within 3 days after surgery (excluding day 3): hb ≥ 90g/l, platelet count ≥ 100×109/l, absolute neutrophil count \> 1.5×109/l; * the expected survival time ≥ 6 months; * the subjects volunteer to sign the informed consent. exclusion criteria: * patients with stage iv breast cancer; * pregnant or lactating women; * those with active bleeding due to various reasons; * those with hiv infection or aids-associated diseases; * those with severe acute and chronic diseases; * those with severe diabetes; * those with serious infectious diseases; * those who can not take drugs by oral route; * drug abusers or those with psychological or mental diseases that may interfere with study compliance; * conditions that are considered not suitable for this study investigators
is mitral velocity time-integral a marker of preload-responsiveness in patients with acute circulatory failure?

Conditions: Preload-responsiveness

Summary: the aim of this is to assess the reliability of the variability of the mitral velocity time-integral with passive leg raising to predict the fluid responsiveness in patients with acute circulatory failure in intensive care.

adult patients with acute circulatory failure will be included in the study. an initial echocardiography is performed in patients placed in a semi-recumbent position. on the apical views (4 and 5-chamber views), the left ventricular outflow tract velocity time integral (lvot-vti) and mitral valve (mv-vti) velocity time integral are measured (baseline values). then a passive leg raise test is performed and the parameters (lvot-vti and mv-vti) are measured again. preload-responsiveness is defined by an increase in lvot-vti of at least 10%. in preload-responsive patients, a fluid loading with 500 ml of 0.9% saline administered over 15 minutes is performed. immediately after fluid therapy, the same parameters are recorded during a third echocardiography. an increase of 10% or more of lvot-vti , compared with baseline, defines fluid responsiveness. patients are monitored using the standard of care practices. hemodynamic assessment includes repetitive echocardiographic examinations if needed. in patients with shock, invasive blood pressure is monitored with an arterial catheter.

Eligibility criteria:
inclusion criteria: acute circulatory failure. exclusion criteria: * recent surgery (\<5 days) * suspected or confirmed intra-abdominal hypertension. * intracranial hypertension. * severe mitral valve disease: severe mitral insufficiency or severe mitral stenosis * acute cor pulmonale * atrial fibrillation * low echogenicity

Keywords: preload-responsiveness acute circulatory failure left ventricular outflow tract velocity time integral mitral valve velocity time integral echocardiography
the effect of atorvastatin on prevention of postoperative acute kidney injury in patients undergoing aortic surgery

Conditions: Aortic Surgery; Acute Kidney Injury

Summary: acute kidney injury(aki) is a common and severe complication after the cardiac surgery. postoperative aki increases the in-hospital stay, intensive care unit(icu) stay and postoperative mortality. aortic surgery is the most risky surgery that causes the postoperative aki, and the incidence of aki after aortic surgery is about 50%. statin is a 3-hydroxy-3-methyl-glutaryl co-enzyme a (hmg coa) reductase inhibitors and is used primarily to lower the level of plasma cholesterol. apart from the antilipid effect, statin has pleiotropic effects include anti-inflammation, decrease of oxidative stress, recovery of endothelial cell injury and stabilization of thrombus. the pathology of aki after aortic surgery include not only hypoperfusion of renal blood flow but also thromboembolism, inflammatory reaction after use of cardiopulmonary bypass(cpb) and oxidative stress. therefore, the incidence of aki after aortic surgery can be expected to decrease after the perioperative use of statin because of the pleiotropic effects of it. the aim of this study is to examine the association between preoperative statin treatment and the incidence of postoperative acute kidney injury(aki) in patients undergoing aortic surgery


Eligibility criteria:
inclusion criteria: 1. the patients undergoing aortic surgery 2. the age: 20\~80 yrs exclusion criteria: 1. taking the statin before the admission 2. having preoperative severe renal dysfunction (egfr \< 15 ml/min per 1.73 m2) 3. past history of liver disease or serum ast/alt increase \> 2-fold from upper normal limit 4. past history of myopathy, myasthenia gravis, rhabdomyolysis or increased creatinine kinase 5. drug or alcohol abuser 6. hypothyroidism 7. taking macrolide, azole antifungals, h2 antagonists, cyclosporine, omeprazole, amiodarone, fibrates and niacin

Keywords: aortic surgery postoperative acute kidney injury statin the patient undergoing aortic surgery
study for a rational management of appendicitis in children

Conditions: Appendicitis

Summary: despite the fact that appendicitis is one of the most frequent surgical pathology in children, its clinical management is still debated. previous reports have shown rate of appendectomy in children without appendicitis up to 30 %. morbidity, due to infectious complications or intestinal obstruction, is often between 5 and 10 % of published cases, and increase medical and social costs. evidence-based medicine concept could therefore be worthwhile in that context, in order to promote rational diagnosis and treatment of that frequent medical condition.an algorithm describing management of children with suspicion of appendicitis was established, based on recent published data, in order to reduce delay between first clinical signs and confirmation of the diagnosis, and to define therapeutic indication such as conservative management and interval appendectomy or patient requiring laparoscopic approach. the main objective of the study is to decrease morbidity and unnecessary appendectomy rates, and secondly to decrease costs, by the use of that algorithm.


Eligibility criteria:
inclusion criteria: * male and female children, between 4 and 15 years-old, with more than 37,5°c of body temperature during the 3 days before hospital admission, and with abdominal pain located in right or median lower quadrant exclusion criteria: * children coming from another hospital, children with septic choc, children with co-morbidity in interaction with algorithm (antibiotics allergy, mellitus diabetes, haemostasis disturbance, ...)

Keywords: appendicitis children
phase ii study of the safety and efficacy of inhaled alpha-1 antitrypsin (aat ) in cystic fibrosis patients

Conditions: Cystic Fibrosis

Summary: cystic fibrosis (cf) is an inherited disorder in which mucus-secreting glands in the lungs produce considerable quantity of thick, sticky secretions that clog the airways, promote bacterial growth and lead to chronic obstruction, inflammation and destruction of the airways. the purpose of this study is to collect data about the resolution of the chronic inflammatory state in addition to assure the safety of the therapy in cf patients.

in cf patients the unregulated inflammatory response overwhelms the normal protease (elastase)/antiprotease (aat) balance, leading to the accumulation of elastase in the lung, destruction of the lung architecture, severe pulmonary dysfunction, and ultimately death. administration of aat is to address the elastase/antiprotease imbalance in order to prevent destruction of the lung tissue and reduce the inflammatory dysregulation that causes pulmonary dysfunction.

Eligibility criteria:
inclusion criteria: * diagnosis of cf by clinical symptoms and positive sweat test or disease inducing mutation. * age \>5 yrs * proven ability to perform reproducible pfts * fev1 \>25% predicted * steady disease state for 3 months and no decrease in lung function exceeding 10% during that period * colonization * stable concomitant therapy \>2 weeks prior to visit 1 and during the study * non-tobacco user of any kind * ability for sputum induction * written informed consent exclusion criteria: * severe cf with an fev1 of \<25% predicted * history of lung transplant * active allergic bronchopulmonary aspergillosis (abpa) * treatment with additional antibiotics (beyond standard cf treatment) for a period of 14 days before study entry (routine antibiotics permitted) * treatment with additional oral and/or iv steroids (beyond standard cf treatment) for a period of 14 days before study entry (screening day) * known hypersensitivity to plasma products * iga deficiency * uncontrolled hypertension * lung surgery in the previous two years * being on any thoracic surgery waiting list * severe concomitant disease * hospitalization within 1 month before study entry, not due to an airway disease * severe liver cirrhosis with ascites * hypersplenism * grade iii/iv oesophageal varices * active pulmonary exacerbation within the 4 weeks prior to screening * history of significant hemoptysis within the previous year * use of tobacco products or recreational drugs * pregnancy or breastfeeding * any serious or active medical or psychiatric illness which, in the opinion of the investigator, would interfere with patient treatment, assessment, or compliance with the protocol. * being a female of child-bearing age without adequate contraception * participation in research study within 1 month
study of coagulation faction viia variant marzeptacog alfa (activated) in adult subjects with hemophilia

Conditions: Hemophilia A; Hemophilia B; Hemophilia A With Inhibitor; Hemophilia B With Inhibitor; Hemophilia A Without Inhibitor; Hemophilia B Without Inhibitor

Summary: this multi-center, open label phase 1 study will evaluate the pharmacokinetics, pharmacodynamics, and safety of a single iv dose of marzaa followed by ascending single sc doses of marzaa in adult subjects with moderate or severe hemophilia a or b, with or without an inhibitor.

this multi-center, open label phase 1 study will evaluate the pharmacokinetics, pharmacodynamics, and safety of a single iv dose of marzaa followed by ascending single sc doses of marzaa in adult subjects with moderate or severe hemophilia a or b, with or without an inhibitor. the study will enroll at least 8 adult male subjects with moderate or severe hemophilia a or b with or without an inhibitor, in each dosing stage. each subject will receive escalating doses of marzaa for each stage of the study (except for stage 5, where subjects receive the same dose as in stage 4 split between two anatomical sites).

Eligibility criteria:
inclusion criteria: * moderate or severe congenital hemophilia a or b, with or without an inhibitor * male, age 18 or older * affirmation of informed consent with signature confirmation before any trial related activities exclusion criteria: * inability to discontinue and washout prophylaxis treatment 72 hours prior to dosing. * previous participation in a trial involving sc administration of rfviia or any trial using a modified amino-acid sequence fviia * known positive antibody to fvii or fviia detected by central laboratory at screening * have a coagulation disorder other than hemophilia a or b, with or without an inhibitor * significant contraindication to participate
misoprostol for the prevention of postpartum hemorrhage in rural pakistan

Conditions: Postpartum Hemorrhage; Anemia

Summary: this community-based trial will study misoprostol for the prevention of postpartum hemorrhage in rural pakistan. traditional birth attendants assisting home deliveries will administer study tablets (600 mcg oral misoprostol or placebo) in the third stage of labor to women participating in the trial. blood loss, hemoglobin levels, side effects, and other variables will be evaluated.


Eligibility criteria:
inclusion criteria: * pregnant women in general good health, home delivery * must live in one of 78 study villages exclusion criteria: * hypertension * non-cephalic presentation * polyhydramnios * previous cesarean section * suspected multiple pregnancy * suspected still birth * antepartum hemorrhage * previous complication in 3rd trimester * anemia of \<8 g/dl

Keywords: postpartum hemorrhage misoprostol maternal morbidity developing countries traditional birth attendants
effects of permissive hypercapnia on concentration of postoperative plasma neurofilament light

Conditions: Hypercapnia

Summary: the aim of this study is to conduct a prospective, single-center randomized controlled study to investigate the changes of plasma nfl concentration in patients undergoing laparoscopic surgery with mild hypercapnia, and further explore its impact on the central nervous system.

plasma nfl concentrations were measured preoperatively and 1 day postoperatively. secondary endpoints:cam (confusion assessment method) is conducted to check the subjects' baseline cognitive function preoperative day and 1 day postoperatively to assess whether delirium occurs.

Eligibility criteria:
inclusion criteria: * age over 60 years * duration of pneumoperitoneum greater than 60 minutes * american society of anesthesiology (asa) status ⅱ-ⅲ * undergoing laparoscopic surgery under general anesthesia with endotracheal intubation exclusion criteria: * history of mental or neurological disorders * preoperative use of antipsychotic drugs * american society of anesthesiology (asa) status ⅳ * severe abnormalities in heart, lung, liver, kidney, and coagulation function * intracranial space-occupying lesions or major cerebrovascular diseases (such as carotid atherosclerosis and cerebral aneurysm) * severe hypertension or hypotension * severe metabolic acidosis or hypercapnic respiratory failure before surgery

Keywords: neurofilament light hypercapnia
the prevention of erythropoietin on cardiac surgery-associated acute kidney injury

Conditions: Acute Kidney Injury; Cardiac Disease; Surgery

Summary: to testify the prevention of erythropoietin on cardiac surgery associated-acute kidney injury, and trying to provide evidence for protecting the renal function and improving the prognosis for patients after cardiac surgery.

patients meet the inclusion criteria and agree to sign an informed consent will be randomly assigned into the control group or erythropoietin group.interventions will be applied 1 day(24hrs) before the cardiac surgery. blood and urine samples will be collected after the surgery. by using the criterion given by kdigo2012 and testing the biomarkers for acute kidney injury, we hope to find out if there is an association between erythropoietin administration and the occurence of acute kidney injury.

Eligibility criteria:
inclusion criteria: 1. preoperative hemoglobin\<130g/l; 2. surgery: valve, coronary artery bypass graft or surgery for congenital heart diseases; 3. volunteers with informed consent. exclusion criteria: 1. patients combined with infection; 2. patients with end-stage renal disease and undergoing renal replacement therapy 3. patients with the history of thromboembolism; 4. patients with malignant tumor and undergoing chemotherapy; 5. patients with unmanageable hypertension (systolic pressure\>200 mmhg or diastolic pressure\>110mmhg); 6. patients allergic to erythropoietin; 7. patients injected erythropoietin within 2 weeks.

Keywords: erythropoietin cardiac surgery associated-acute kidney injury
efficacy and safety of sar156597 in the treatment of idiopathic pulmonary fibrosis

Conditions: Idiopathic Pulmonary Fibrosis

Summary: primary objective: to evaluate, in comparison with placebo, the efficacy of 2 dose levels/regimens of sar156597 administered subcutaneously during 52 weeks on lung function of participants with idiopathic pulmonary fibrosis (ipf). secondary objectives: to evaluate the efficacy of 2 dose levels/regimens of sar156597 compared to placebo on ipf disease progression. to evaluate the safety of 2 dose levels/regimens of sar156597 compared to placebo in participants with ipf.

the total study duration of study was expected up to 68 weeks (screening period of 4 weeks, treatment period of 52 weeks, and 12 weeks of follow up).

Eligibility criteria:
inclusion criteria : * adult male or female participants. * documented diagnosis of ipf according to the current 2011 american thoracic society/european respiratory society/japanese respiratory society/ american latin thoracic association (ats/ers/jrs/alat) guidelines. * signed written informed consent. exclusion criteria: * age less than or equal to 40 years. * ipf disease diagnosis greater than 5 years. * forced vital capacity (fvc) less than (\<) 40 percent (%) of predicted value. * carbon monoxide diffusing lung capacity (dlco) corrected for hemoglobin \<30% of predicted value. * severe chronic obstructive bronchitis as characterized by forced expiratory volume in 1 second /forced vital capacity (fev1/fvc) \<0.70. * need for 24 hours of oxygen therapy or oxygen saturation \<88% after 10 minutes breathing ambient air at rest. * known diagnosis of significant respiratory disorders other than ipf. * pulmonary artery hypertension requiring a specific treatment. * currently listed and/or anticipated for lung transplantation within the next 6 months (on an active list). * history of vasculitis or connective tissue disorders. * known human immunodeficiency virus or chronic viral hepatitis. * participants with active tuberculosis or incompletely treated latent tuberculosis infection. * use of any cytotoxic/immunosuppressive agent including but not limited to azathioprine, cyclophosphamide, methotrexate, and cyclosporine within 4 weeks prior to screening. * use of any cytokine modulators (etanercept, adalimumab, efalizumab, infliximab, golimumab, certolizumab, rituximab) within 12 weeks or 5 half-lives of screening (24 weeks for rituximab and 24 months for alefacept). * use of any investigational drug within 1 month of screening, or 5 half-lives, if known ( whichever was longer), or within 12 weeks for stem cell therapy. the above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
the effects of azithromycin ophthalmic solution, 1% versus placebo in subjects with blepharitis during a two-week treatment period

Conditions: Blepharitis

Summary: the objective of this study is to compare the safety and efficacy of azithromycin ophthalmic solution, 1% versus placebo over a two-week treatment period.


Eligibility criteria:
inclusion criteria: * have best corrected visual acuity in both eyes of at least +0.7 or better * if female, are non-pregnant or non-lactating * have a current diagnosis of blepharitis in one or both eyes exclusion criteria: * have lid structural abnormalities * have suspected ocular fungal or viral infection * have practiced warm compress therapy within 14 days prior to visit 2 * unable to withhold the use of contact lenses during the treatment or follow-up periods * unable to withhold the use of ocular cosmetic products within 24 hours prior to study visits * have had penetrating intraocular surgery within 90 days prior to visit 2 * have had ocular surface surgery within the past year prior to visit 2 * have a serious medical condition which could confound study assessments